Chelsea Therapeutics Reports Fourth Quarter and Full-Year 2012 Results

Chelsea Therapeutics Reports Fourth Quarter and Full-Year 2012 Results

CHARLOTTE, N.C., March 7, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today reported financial results for the
fourth quarter and full year ended December 31, 2012.

Fourth Quarter and Recent Highlights

  *In February 2013, Chelsea received written guidance from the Director of
    the Office of New Drugs at the U.S. Food and Drug Administration (FDA)
    stating that Study 306B has the potential to serve as the basis for a
    resubmission of a Northera (droxidopa) New Drug Application (NDA) for the
    treatment of symptomatic neurogenic orthostatic hypotension (NOH). The
    guidance suggested that "data strongly demonstrating a short-term clinical
    benefit… of droxidopa in patients with NOH would be adequate for approval,
    with a possible requirement to verify durable clinical benefit
    post-approval." It further notes that any decision regarding the outcome
    of an FDA review, to be performed by the DCRP will be based on the
    strength of Study 306B and its ability to provide substantial evidence of
    effectiveness to support approval.

  As a result of FDA's guidance, the Company intends to resubmit the Northera
  NDA in late second quarter 2013. Chelsea also intends to initiate a new
  clinical trial in the fourth quarter of 2013, given FDA guidance regarding
  the potential need for Chelsea to verify the durability of effect of
  Northera in a post-marketing study. This study would also include short-term
  clinical endpoints should the Agency require an additional clinical trial
  for the approval of Northera.

  *In December 2012, Chelsea reported that Study 306B demonstrated
    statistically significant improvements for Northera compared to placebo in
    dizziness/lightheadedness at week 1 (p=0.018), the primary endpoint, and
    increase in standing systolic blood pressure at week 1 (p=0.032), an
    important secondary endpoint. Treatment with Northera also resulted in a
    reduction in patient falls and fall-related injuries, although the results
    were not significant. The safety data were consistent with previous
    studies, and showed that Northera was well tolerated.
    
  *In November 2012, Chelsea announced positive results from a clinical study
    of Northera in hypotensive individuals with spinal cord injury (SCI) at
    the 23^rdInternational Symposium on the Autonomic Nervous System.These
    preliminary data indicated that Northera increases seated blood pressure
    in a dose dependent manner without worsening supine increases in blood
    pressure in hypotensive patients with SCI, suggesting a greater
    normalization of blood pressure across positional changes.

"Chelsea now has a regulatory path forward for Northera in NOH.We look
forward to interacting with FDA to provide the necessary analyses for a
thorough review of our resubmitted NDA and to collaborate on the design of the
next clinical study," said Joseph G. Oliveto, Interim CEO of Chelsea. "As
previously announced, we ended 2012 with cash and cash equivalents of
approximately $28.4 million.We will continue to diligently manage our
existing funds which we expect will fund operations into the third quarter of
2014, well past the currently projected Northera approval determination date."

Financial Results for the Fourth Quarter

For the quarter ended December 31, 2012, Chelsea reported a net loss of $2.2
million or ($0.03) per share versus a net loss of $12.5 million or ($0.20) per
share for the same period in 2011. For the twelve months ended December 31,
2012, Chelsea reported a net loss of $31.7 million or ($0.47) per share
compared to a net loss of $50.5 million or ($0.84) per share for the same
period in 2011.

Research and development (R&D) expenses for the fourth quarter of 2012 were
$0.9 million, compared to $7.7 million for the same period in 2011. For the
twelve months ended December 31, 2012, research and development expenses were
$16.7 million, versus $37.3 million for the comparable prior-year period. The
reduction in R&D costs is primarily due to the completion of multiple studies
in both the droxidopa and antifolate development programs.

Selling, general and administrative (SG&A) expenses were $1.4 million for the
three months ended December 31, 2012, compared to $4.8 million for the same
period in 2011. For the twelve months ended December 31, 2012, SG&A expenses
were $12.9 million, compared to $13.3 million for the prior-year period. The
period to period changes in SG&A costs are primarily related to our
significant spending on Northera commercialization and launch preparation
activities that occurred during the latter half of 2011 and the first half of
2012.By the end of the second quarter of 2012, the majority of these
activities had been brought to a close as related vendor contracts were
cancelled and projects were finalized subsequent to receipt of the Complete
Response Letter from the FDA in March 2012.

Chelsea ended the year with $28.4 million in cash and cash equivalents
compared to $45.6 million, including short-term investments, as of December
31, 2011. Chelsea anticipates that its cash and cash equivalents on hand
should fund the Company's operations into the third quarter of 2014. While
details for a future clinical trial for Northera are yet to be determined,
this projection assumes a new trial would commence dosing in the fourth
quarter of 2013.In addition to the initial costs of a new trial, assumptions
underlying this guidance cover costs related to the NDA re-submission.This
current forecast does not include material activities related to an NDA
approval or the commercialization of Northera.

About Northera

NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics'
pipeline, is currently in Phase III development for the treatment of
symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary
autonomic failure – an indication that includes a significant number of
patients with Parkinson's disease, multiple system atrophy (MSA) and pure
autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is
directly converted to norepinephrine (NE) via decarboxylation, resulting in
increased levels of NE in the nervous system, both centrally and peripherally.

About Chelsea Therapeutics

Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company
that acquires and develops innovative products for the treatment of a variety
of human diseases, including central nervous system disorders. Chelsea is
currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a
novel, late-stage, orally-active therapeutic agent for the treatment of
symptomatic neurogenic orthostatic hypotension in patients with primary
autonomic failure. For more information about the Company, visit
www.chelseatherapeutics.com

This press release contains forward-looking statements regarding future events
including our intention to pursue the development of Northera. These
statements are subject to risks and uncertainties that could cause the actual
events or results to differ materially. These include reliance on key
personnel and our ability to attract and/or retain key personnel, risks of
distraction of the Board and management at this critical time; the risk that
the FDA will not accept our proposal regarding any trial or other data to
support a new drug application; the risk that we will not be able to resubmit
the NDA for Northera and that the FDA will not approve a resubmitted NDA; the
risk that our resources will not be sufficient to conduct any study of
Northera that will be acceptable to the FDA; the risk that we cannot complete
any additional study for Northera without the need for additional capital; the
risks and costs of drug development and that such development may take longer
or be more expensive than anticipated; our need to raise additional operating
capital in the future; our reliance on our lead drug candidate droxidopa; risk
of regulatory approvals of droxidopa or our other drug candidates for
additional indications; risk of volatility in our stock price, related
litigation, and analyst coverage of our stock; reliance on collaborations and
licenses; intellectual property risks; our history of losses; competition;
market acceptance for our products if any are approved for marketing.

CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                                                           
                                                           
                                                             Period from
                                                            April 3, 2002
              For the years ended December 31,               (inception)
                                                               through
              2012            2011            2010            December 31,
                                                               2012
                                                            
Operating                                                   
expenses:
Research and   $16,744,423   $37,270,138   $30,871,125   $162,504,846
development
Sales and      7,221,800      8,067,709      2,476,494      24,246,376
marketing
General and    5,679,485      5,276,146      4,154,944      30,903,158
administrative
Restructuring  2,157,795      --            --            2,157,795
Total
operating      31,803,503     50,613,993     37,502,563     219,812,175
expenses
                                                           
Operating loss (31,803,503)   (50,613,993)   (37,502,563)   (219,812,175)
Interest       67,594         161,828        242,883        5,009,113
income
Interest       --            --            (70,389)       (258,348)
expense
                                                           
Net loss       $(31,735,909) $(50,452,165) $(37,330,069) $(215,061,410)
                                                           
Net loss per
basic and
diluted share  $(0.47)       $(0.84)       $(0.91)       
of common
stock
                                                           
Weighted
average number
of basic and   66,892,982     60,136,326     41,184,623     
diluted common
shares
outstanding



CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
                                                                          
                                                                          Period from
              For the three months ended  For the twelve months ended     April 3, 2002
              December 31,                  December 31,                   (inception) to
              2012           2011            2012            2011            December 31,
                                                                              2012
                                                                         
Operating                                                                 
expenses:
Research and   $870,287     $7,712,687    $16,744,423   $37,270,138   $162,504,846
development
Sales and      278,472       3,428,463      7,221,800      8,067,709      24,246,376
marketing
General and    1,149,050     1,347,891      5,679,485      5,276,146      30,903,158
administrative
Restructuring  (60,552)      --            2,157,795      --            2,157,795
Total
operating      2,237,257     12,489,041     31,803,503     50,613,993     219,812,175
expenses
                                                                         
Operating loss (2,237,257)   (12,489,041)   (31,803,503)   (50,613,993)   (219,812,175)
Interest       9,150         30,708         67,594         161,828        5,009,113
income
Interest       --           --            --            --            (258,348)
expense
                                                                         
Net loss       $(2,228,107) $(12,458,333) $(31,735,909) $(50,452,165) $(215,061,410)
                                                                         
Net loss per
basic and
diluted share  $(0.03)      $(0.20)       $(0.47)       $(0.84)       
of common
stock
                                                                         
Weighted
average number
of basic and   67,058,174    61,893,905     66,892,982     60,136,326     
diluted common
shares
outstanding
                                                                                              
See accompanying notes to condensed consolidated financial statements.                         



CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
Condensed Consolidated Balance Sheet Data
(unaudited)
                                                            
                                                December 31, December 31,
                                                2012         2011
                                                (in thousands)
                                                            
Cash and cash equivalents                        $28,425    $41,106
Short-term investments                           --         4,500
Total assets                                     28,928      46,903
Total liabilities                                3,011       13,238
Deficit accumulated during the development stage (215,061)   (183,326)
Stockholders' equity                             25,916      33,665

CONTACT: Investors:
         Fara Berkowitz / Susan Kim
         Argot Partners
         212-600-1902
         fara@argotpartners.com
         susan@argotpartners.com
        
         Media:
         David Pitts
         Argot Partners
         212-600-1902
         david@argotpartners.com

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